Att B - 60 day FRN

71796

Federal Register / Vol. 77, No. 233 / Tuesday, December 4, 2012 / Notices

There will be no cost to the
respondents other than their time. The
total burden is 216.

ESTIMATED ANNUALIZED BURDEN HOURS

Phase I ..................................

Respondents

Form name

Section Foreman ..................

Phase I Section Foreman
Form.
Phase I Baseline Form .........
Phase I 1month form ............
Phase I Focus Group Questions.
Phase II Section Foreman
Form.
Phase II Baseline Form ........
Phase II 1, 3, and 6 months
forms.

Mine Workers .......................
Mine Workers .......................
Mine Workers .......................
Phase II .................................

Section Foreman ..................
Mine Workers .......................
Mine Workers .......................

Dated: November 26, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.

burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Written comments should
be received within 60 days of this
notice.

[FR Doc. 2012–29182 Filed 12–3–12; 8:45 am]
BILLING CODE 4163–18–P

Proposed Project
Laboratory Medicine Best Practices
Project (LMBP), OMB Control Number
0920–0848, Expiration 5/31/2013—
EXTENSION—Office of Surveillance,
Epidemiology and Laboratory Services
(OSELS), Centers for Disease Control
and Prevention (CDC).

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day-13–0848]

mstockstill on DSK4VPTVN1PROD with

Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 and
send comments to Ron Otten, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the

VerDate Mar<15>2010

17:31 Dec 03, 2012

Jkt 229001

Background and Brief Description
CDC is seeking approval from the
Office of Management and Budget
(OMB) to collect information from
healthcare organizations in order to
conduct systemic evidence reviews of
laboratory practice effectiveness. The
purpose of information collection is to
include completed unpublished quality
improvement studies/assessments
carried out by healthcare organizations
(laboratories, hospitals, clinics) in
systematic reviews of practice
effectiveness. CDC has been sponsoring
the Laboratory Medicine Best Practices
initiative to develop new systematic
evidence reviews methods for making
evidence-based recommendations in
laboratory medicine. This initiative
supports the CDC’s mission of
improving laboratory practices. The
focus of the Initiative is on pre- and
post-analytic laboratory medicine
practices that are effective at improving
health care quality. While evidence
based approaches for decision-making
have become standard in healthcare,
this has been limited in laboratory
medicine. No single-evidence-based

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No. of
responses per
respondent

No. of
respondents

Average
burden per
response
(in hours)

3

1

30/60

27
27
27

1
1
1

20/60
30/60
1

6

12

10/60

54
54

1
6

20/60
25/60

model for recommending practices in
laboratory medicine exists, although the
number of laboratories operating in the
United States and the volume of
laboratory tests available certainly
warrant such a model. The Laboratory
Medicine Best Practices Initiative began
in October 2006, when CDC convened
the Laboratory Medicine Best Practices
Workgroup (Workgroup), a
multidisciplinary panel of experts in
several fields including laboratory
medicine, clinical medicine, health
services research, and health care
performance measurement. The
Workgroup has been supported by staff
at CDC and the Battelle Memorial
Institute under contract to CDC. To date,
the Laboratory Medicine Best Practices
(LMBP) project work has been
completed over three phases. During
Phase 1 (October 2006–September
2007)of the project, CDC staff developed
systematic review methods for
conducting evidence reviews using
published literature, and completed a
proof-of-concept test. Results of an
extensive search and review of
published literature using the methods
for the topic of patient specimen
identification indicated that an
insufficient quality and number of
studies were available for completing
systematic evidence reviews of
laboratory medicine practice
effectiveness for multiple practices, and
hence for making evidence-based
recommendations. These results were
considered likely to be generalizable to
most potential topic areas of interest. A
finding from Phase 1 work was that
laboratories would be unlikely to
publish quality improvement projects or
studies demonstrating practice
effectiveness in the peer reviewed
literature, but that they routinely

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71797

Federal Register / Vol. 77, No. 233 / Tuesday, December 4, 2012 / Notices
conducted quality improvement projects
and had relevant data for completion of
evidence reviews. Phase 2 (September
2007–November 2008) and Phase 3
(December 2008–September 2009),
involved further methods development
and pilot tests to obtain, review, and
evaluate published and unpublished
evidence for practices associated with
the topics of patient specimen
identification, communicating critical
value test results, and blood culture
contamination. Exploratory work by

LMBP registrant network and submit
readily available unpublished studies;
quality improvement projects,
evaluations, assessments, and other
analyses relying on unlinked,
anonymous data using the LMBP
Submission Form. LMBP registrants will
also be able to submit unpublished
studies/data for evidence reviews on an
annual basis using this form. There is no
cost to respondents other than their
time.

CDC supports the existence of relevant
unpublished studies or completed
quality improvement projects related to
laboratory medicine practices from
healthcare organizations. The objective
for successive LMBP evidence reviews
of practice effectiveness is to
supplement the published evidence
with unpublished evidence to fill in
gaps in the literature. Healthcare
organizations and facilities (laboratory,
hospital, clinic) will have the
opportunity to voluntarily enroll in an

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden per
response
(in hrs)

Total burden
(in hours) *

Healthcare Organizations ................................................................................

150

1

40/60

100

Total ..........................................................................................................

........................

........................

........................

100

Dated: November 26, 2012.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.

ways to enhance the quality, utility, and
clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of information technology. Written
comments should be received within 60
days of this notice.

[FR Doc. 2012–29176 Filed 12–3–12; 8:45 am]
BILLING CODE 4163–18–P

Proposed Project
School Dismissal Monitoring System
(OMB Control No. 0920–0849 Exp. 5/31/
2013)—Revision—National Center
Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day-13–0849]

Proposed Data Collections Submitted
for Public Comment and
Recommendations

mstockstill on DSK4VPTVN1PROD with

No. of
responses per
respondent

No. of
respondents

Respondents

In compliance with the requirement
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–7570 and
send comments to Ron Otten, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments are invited on (a) whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have a
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)

VerDate Mar<15>2010

17:31 Dec 03, 2012

Jkt 229001

Background and Brief Description
In the spring of 2009, the beginning of
H1N1 influenza pandemic, illness
among school-aged students (K–12) in
many states and cities resulted in at
least 1,351 school dismissals due to
rapidly increasing absenteeism among
students or staff. These dismissals
impacted at least 824,966 students and
53,217 teachers. During that time, the
U.S. Department of Education (ED) and
the Centers for Disease Control and
Prevention (CDC) received numerous
daily requests about the overall number
of school dismissals nationwide and the
number of students and teachers
impacted by the school dismissals. CDC
and ED recognized the importance of
having a mechanism in place to collect
this information and gauge the impact of
school dismissals during the pandemic.
Although an informal process was put
in place in conjunction with ED to track
school closures, there was no formal
monitoring system established.
Consequently, CDC and ED launched
the School Dismissal Monitoring System

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to track reports of school closures
during public health emergencies and
generate accurate, real-time, national
summary data daily on the number of
closed schools and the number of
students and teachers impacted by the
dismissals. The system, initially
approved under OMB Control No. 0920–
0008, Emergency Epidemic
Investigations, facilitated CDC’s and
ED’s efforts to track implementation of
CDC pandemic guidance, characterized
factors associated with differences in
morbidity and mortality due to
pandemic influenza in the schools and
surrounding communities, and
described the characteristics of the
schools experiencing outbreaks as well
as control measures undertaken by those
schools. In the fall of 2009, CDC’s
School Dismissal Monitoring System
detected 1,947 school dismissals
impacting approximately 623,616
students and 40,521 teachers
nationwide. These data were used
widely throughout the U.S. Government
for situational awareness and
specifically at CDC to assess the impact
of CDC guidance and community
mitigation efforts in response to the
2009 H1N1 influenza pandemic.
The purpose of this monitoring
system is to generate accurate, real-time,
national summary data daily on the
number of school dismissals and the
number of students and teachers
impacted by the dismissals due to
public health emergencies. This
collection request includes dismissals
initiated for infectious disease outbreaks
or weather related events when school
dismissals are recommended by federal,
state or local public health authorities.

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